Compounding still has an important role when individual patients need medicines that commercially available products cannot provide. But shortage-era mass production should end when the shortage does. The FDA is right to enforce that distinction.
The U.S. Food and Drug Administration’s effort to rein in mass-market copies of blockbuster GLP-1 drugs just survived a major legal challenge.
Last month, the U.S. Court of Appeals for the Fifth Circuit upheld the agency’s determination that the shortage of semaglutide—the active ingredient in Ozempic and Wegovy—is over. In a companion case, the court reached the same conclusion about tirzepatide, the active ingredient in Mounjaro and Zepbound.
The challenges came from compounders that had been allowed to make copies of these drugs during the shortages—and weren’t eager to give up that business once supplies recovered. But that exception existed to address scarcity, not to create a permanent competing market in unapproved copies. Now that the shortages are over, compounding should return to its proper, limited role in the drug supply chain.
Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.
The GLP-1 Shortage Is Over. Mass-Market Compounding Should Be, Too
Sally C. Pipes
Compounding still has an important role when individual patients need medicines that commercially available products cannot provide. But shortage-era mass production should end when the shortage does. The FDA is right to enforce that distinction.
The U.S. Food and Drug Administration’s effort to rein in mass-market copies of blockbuster GLP-1 drugs just survived a major legal challenge.
Last month, the U.S. Court of Appeals for the Fifth Circuit upheld the agency’s determination that the shortage of semaglutide—the active ingredient in Ozempic and Wegovy—is over. In a companion case, the court reached the same conclusion about tirzepatide, the active ingredient in Mounjaro and Zepbound.
The challenges came from compounders that had been allowed to make copies of these drugs during the shortages—and weren’t eager to give up that business once supplies recovered. But that exception existed to address scarcity, not to create a permanent competing market in unapproved copies. Now that the shortages are over, compounding should return to its proper, limited role in the drug supply chain.
Read the entire op-ed here.
Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.